This is a critical question, as each of the specific aims in the application must meet the following criteria to be considered responsive. The project must:

• Address the research focus of the NOFO
• Fall within the scope of FDA CTP’s regulatory authority

As such, applicants are strongly encouraged to contact the NIH Scientific/Research Contact(s) listed in Section VII of NOFOs for feedback about responsiveness prior to submitting an application. Sharing your research ideas and specific aims and submitting a letter of intent prior to applying will allow NIH staff to provide responsiveness feedback.

If your application is deemed responsive, it will undergo scientific peer review by experts convened specifically for that purpose (by the NIH Center for Scientific Review). If your application is deemed nonresponsive, it will be withdrawn prior to evaluation of its scientific merit (i.e., peer review). Program officials will let you know if the application must be withdrawn from peer review.

An LOI is not required, and it is not part of the peer review process. However, it allows NIH staff to estimate the potential review workload and plan the review. We suggest sending the LOI 60 days before the application due date. Investigators are encouraged to send their specific aims with their LOI so that the NIH Scientific/Research Contacts can review their research ideas and aims before they submit applications, as all proposed specific aims must be within the regulatory authority of FDA CTP in order to be deemed responsive. Applications that are nonresponsive will not be reviewed.

Suggested content of LOI:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the program director(s)/principal investigator(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity
• Specific aims

The letter may be sent by email to: [email protected]

Tel: 301-451-7464
Fax: 301-480-2230

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) gave FDA responsibility and authority to, among other things:

• Restrict the sale and distribution of tobacco products, including advertising and promotion, as appropriate to protect public health
• Review modified-risk tobacco product applications, such as those marketed for use to reduce harm, prior to their introduction to the market
• Adjust warning labels for cigarettes and smokeless tobacco products in order to promote greater public understanding of the risks of tobacco use
• Establish standards for tobacco products (e.g., setting limits on harmful and potentially harmful constituents and nicotine levels) as appropriate to protect the public health
• Review new tobacco products prior to their introduction to the market

For more information, see Family Smoking Prevention and Tobacco Control Act - An Overview.

Research is encouraged in the following scientific domains: 

• Chemistry and engineering
• Toxicity
• Addiction
• Health effects
• Behavior
• Communications
• Marketing influences
• Impact analysis

The Tobacco Control Act gives FDA the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by youth. In general, FDA CTP’s regulatory authorities do NOT extend to the following:

• Setting tax rates for tobacco products
• Regulating therapeutic products, such as those marketed to treat tobacco dependence (regulated by other parts of FDA)
• Setting clean indoor air policies
• Regulating tobacco growing
• Requiring the reduction of nicotine yields to zero
• Providing cessation services
• Banning all cigarettes, smokeless tobacco products, little cigars, other cigars, pipe tobacco, or roll-your-own tobacco products
• Changing the minimum age to purchase tobacco products
• Mechanistic studies (i.e., basic science of disease development), unless biomarkers of harm with predictive value for disease development associated with tobacco product use is an outcome 

Yes. An application identifying differential effects of various tobacco products on disease would be responsive. Examples might include:

• Pulmonary function-testing outcomes following use of various combustible tobacco products
• Oral manifestations following use of various tobacco products, especially new and emerging tobacco products

It depends. Mechanistic and/or etiologic research is largely relevant to disease prevention or treatment, neither of which is within FDA CTP’s regulatory authority, so would not be considered responsive. These types of research may, in some cases, be responsive, but only if the outcomes of the research inform the mandate of FDA CTP. For example, research that identifies which constituents and/or flavors in a particular tobacco product contribute to disease outcomes may be considered responsive. 

No. FDA CTP’s regulatory authority does not extend to regulating therapeutic uses of tobacco products, as this authority rests with other centers within FDA. However, examples of research projects that would be considered responsive include: (1) an observational study to examine the natural history of whether participants quit smoking cigarettes while using a different tobacco product, and (2) assessing if communications regarding the health consequences of using tobacco products have an impact on usage rates. In many of its key regulatory areas, FDA CTP is charged with assessing the impact of tobacco products on the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products—as well as the increased or decreased likelihood that existing users of tobacco products will stop using such products, and the increased or decreased likelihood that those who do not use tobacco products will start using such products. 

No. FDA CTP does not regulate products or support development of clinical interventions intended for the treatment of disease. For example, pharmacotherapy for treatment of cancer or emphysema, screening, physical activity, or dietary interventions for heart disease would all be considered nonresponsive. 

It depends. As FDA CTP cannot set clean indoor air policies, research investigating secondhand or thirdhand smoke that is designed to evaluate or support these policies would not be responsive. Studies examining the health effects of these exposures that could inform potential regulation of tobacco products may be responsive. For example, examination of the health impact of secondhand and/or thirdhand exposures due to electronic cigarette (e-cigarette) constituents or device parameters may be responsive. 

No. A study with marijuana as the primary outcome is not responsive because FDA CTP does not regulate marijuana under its tobacco product authorities. However, research designed to evaluate the extent to which e-cigarette users are using marijuana in their tobacco products as a means to more accurately characterize or assess tobacco product use behavior is responsive to FDA CTP authorities.

If the research provides information on outcomes such as motor activity, memory, or neuronal responses to particular ligands, the research is likely not responsive. Research to rapidly screen tobacco constituents for activity at the nicotinic receptor to determine their dependence potential would be considered responsive.

Applications identifying biomarkers of specific tobacco product exposure and/or disease and those with the potential to differentiate exposure of differing tobacco products could be considered responsive. Examples include: 

• Biomarkers to measure exposure to new and emerging tobacco products
• Biomarkers of disease (e.g., cancer, cardiovascular disease, pulmonary disease, and reproductive and developmental effects) that can be associated with specific measures of tobacco exposure
• Development of a nonclinical biomarker of disease coupled with traditional toxicology and/or pharmacology studies to provide a relevant framework for the regulatory application
• Studies linking biomarkers of disease in nonclinical models that translate to biomarkers that are measurable in the clinical setting
• Magnitude of changes in biomarkers that translates into clinically meaningful impacts on human health outcomes

Biomarker research may fall within the scope of one or more FDA CTP interest areas, depending on the intended use of the biomarker. However, some biomarker research will remain outside of FDA CTP authorities, such as biomarker research with a primary focus to inform treatment.

Studies examining the impact of pharmacies or other types of stores ceasing the sale of tobacco products are not responsive, as FDA cannot ban face-to-face sales in a particular category of retail outlets. However, a study proposing to understand how minors can access (use behavior) tobacco products in these establishments may be of interest to FDA CTP.

It depends. If a vape shop is a retail establishment that sells tobacco products for personal consumption, FDA CTP has the authority to regulate the following retailer requirements:  

• Checking ID to assure appropriate age for sales
• Not selling tobacco products to persons under the age of 21 
• Not selling tobacco products via vending machines unless in an adult-only facility
• Not breaking open packages to sell smaller amounts
• Not giving away free samples to consumers (exception is free samples of smokeless tobacco can be provided in limited quantities in “qualified adult-only facilities”)
• Only selling tobacco products and displaying advertisements that contain proper health warning statement(s)

See the Selling Tobacco Products in Retail Stores webpage for a list of retailer requirements.

Given FDA CTP’s authority as it relates to vape shops as described above, an example of responsive research is understanding knowledge, attitudes, and behaviors of vape shop customers and retailers to inform communications about the health effects of electronic nicotine delivery systems (ENDS). An example of research that would not be responsive is a study that assesses whether retail locations are opened or closed, as FDA CTP does not regulate the number, type, location, proximity, or density of retail establishments.

The following types of analyses are examples of topics that would be considered responsive under “impact analysis”:

• Computational/mathematical modeling and simulation and/or statistical modeling of the public health impact of potential FDA CTP action
• Health and economic impact of tobacco use and/or tobacco regulatory policies on vulnerable populations
• Economic burden (e.g., health care cost, productivity loss) of tobacco-related diseases on users and nonusers (e.g., secondhand and thirdhand exposure)
• Studies evaluating the impact of tobacco regulatory actions (e.g., mandated changes in product characteristics) on consumer behavior or behavioral intentions 

No. As FDA CTP does not have the authority to set tobacco product prices or set tobacco taxes, research meant to inform pricing would not be responsive. 

It depends upon the specific policies being examined and whether they fall under the purview of FDA CTP. Studies evaluating the impact of a tobacco tax increase are not responsive, as FDA CTP does not have regulatory authority regarding tax rates on tobacco products. Similarly, FDA CTP does not have authority over the sale of tobacco cessation medications. For example, a study evaluating the effectiveness for tobacco cessation of providing free nicotine replacement therapy would not be considered responsive. However, studies evaluating the impact of a tobacco advertising restriction, a ban on the sale of flavored tobacco products, restrictions on price promotions such as coupons and discounts, or restrictions on the sale of single-serving products may be considered responsive.

No. Unlike state or local policymaking, where public support can be an important factor in the adoption and implementation of policies, public opinions about potential or proposed tobacco regulatory actions cannot be used to support federal regulations. However, research examining public understanding of regulations or social norms or perceptions of tobacco products may be responsive.

Potentially, yes. If the product(s) meets the statutory definition of a “tobacco product” under the Tobacco Control Act (i.e., any product made or derived from tobacco and intended for human consumption, including any component, part, or accessory of a tobacco product), then studies examining these products could be considered responsive. However, the application must demonstrate that the proposed research can directly contribute to FDA CTP’s regulatory authority over the manufacture, marketing, and distribution of tobacco products within the United States.

Foreign populations may be included. However, results from research in foreign populations must be relevant to the U.S. population and U.S. regulation of tobacco products. For example, studies assessing biomarkers of exposure, biomarkers of potential harm, and health effects would be relevant to the extent that the findings could be generalized to the United States. Studies assessing the impact of policies that FDA could replicate in the United States would be relevant. Studies assessing general knowledge or attitudes about tobacco products among foreign populations would not likely be relevant.

Potentially, yes. While a heated product is a tobacco product as defined in the Tobacco Control Act and would fall under the regulatory authority of FDA CTP as a result of the deeming rule, both the responsiveness of a study investigating this product and its relevance to FDA CTP priorities would depend upon the type of research being proposed. 

Yes, studies in vulnerable populations are responsive to FDA CTP regulatory authorities. However, the population needs to be appropriate to the research question. FDA CTP recommends research studies to include, where appropriate to the research question, populations of special relevance including (but not limited to): youth and young adults, those with lower socioeconomic status, certain races or ethnicities, sexual or gender minorities, underserved rural populations, those pregnant or trying to become pregnant, those in the military or veterans, and those with mental health conditions or substance use disorders.